| |  | The Lead Brief | The Food and Drug Administration may have given companies like Hims & Hers and Ro that make “personalized” versions of GLP-1 weight loss drugs a green light — taking on a $68 billion question. The FDA announced it would be creating a “green list” of approved importers for the active pharmaceutical ingredients, or API, used to make the medicines, as a way of keeping unsafe ingredients out of the final product. The list comes as drugmakers Novo Nordisk and Eli Lilly, the makers of Wegovy and Mounjaro, have pressed federal regulators to take greater action against those making copycat versions of the drugs and moved to sue compounding facilities that make them. (Novo has filed 132 lawsuits in total.) They’ve warned that unsafe ingredients are being imported into the U.S. But companies that make compounded semaglutide and tirzepatide — the active ingredients in Wegovy and Mounjaro, respectively — are hailing the move as an implicit signal that they’re free to continue operating. The $68 billion question There’s a huge pot of money at stake: Some analysts estimate the U.S. market for anti-obesity medication could reach $68 billion by 2034. Following the FDA’s release of the green list, telehealth company Hims, which makes its own semaglutide, cheered the move to crack down on dangerous imports. “But it also sends a quieter signal: legitimate compounders (like $HIMS) sourcing from vetted, compliant manufacturers are free to keep operating,” the company posted on X. “For a year now, we have heard from pharma manufacturers that it was illegal to compound GLP-1 medications. The FDA, through the acknowledgement of the green list, as well as their recent actions on adverse events, has implicitly acknowledged that compounding GLP-1s can occur,” said Lee Rosebush, the chairman of the Outsourcing Facilities Association, which represents the bulk compound pharmacies. A spokesperson for HHS wouldn’t specifically address whether the list is an implicit endorsement of compounded GLP-1s and emphasized that the products have not been approved by the FDA or evaluated for their safety or effectiveness. “The FDA has consistently emphasized that compounded drugs should only be used when a patient’s medical needs cannot be met by an FDA-approved product, or when the approved drug is not commercially available,” the agency said. Eli Lilly maintains that the mass compounding of its medicines is against the law and called the FDA’s green list “an important first step that significantly narrows sources of illegal importation.” “No one should be mass compounding tirzepatide, and we urge FDA and other regulators to continue taking enforcement action and other steps to stop unlawful compounding before more people get hurt,” a spokesperson for Eli Lilly emailed me. A spokesperson for Novo Nordisk echoed the need to continue a crackdown, saying the company has been “sharing information related to this patient safety issue with FDA, other regulators and law enforcement who have the shared responsibility to protect public health and safety.” → The difference in opinion only means the showdown between these forces is nowhere close to being over. This battle is likely to continue in the public policy arena and in the courts. BUT. Although Novo Nordisk and Eli Lilly have filed more than 100 lawsuits against compound manufacturers making copycats, none of them have focused on intellectual property violations. The companies haven’t said why. “The bigger question is, are the sponsor companies going to eventually file a quote-unquote ‘real’ lawsuit against compounders?” said Jacob Sherkow, a professor of law and medicine at the University of Illinois who specializes in intellectual property and is following the GLP-1 litigation. “What are these patents good for if you're not going to use them when you otherwise need to? From the way the companies are talking about it and litigating it, it really does seem like the end of the earth for their franchises,” he said. | 
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